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Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial.

ABSTRACT: Both oral contraceptive pills (OCPs) and estradiol (E2) valerate have been used to schedule gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles and, consequently, laboratory activities. However, there are no studies comparing treatment outcomes directly between these two pretreatment methods. This randomized controlled trial was aimed at finding differences in ongoing pregnancy rates between GnRH antagonist IVF cycles scheduled with OCPs or E2 valerate.Between January and May 2012, one hundred consecutive patients (nonobese, regularly cycling women 18-38 years with normal day 3 hormone levels and <3 previous IVF/ICSI attempts) undergoing IVF with the GnRH antagonist protocol were randomized to either the OCP or E2 pretreatment arms, with no restrictions such as blocking or stratification. Authors involved in data collection and analysis were blinded to group assignment. Fifty patients received OCP (30 ?g ethinyl E2/150 ?g levonorgestrel) for 12-16 days from day 1 or 2, and stimulation was started 5 days after stopping OCP. Similarly, 50 patients received 4 mg/day oral E2 valerate from day 20 for 5-12 days, until the day before starting stimulation.Pretreatment with OCP (mean±SD, 14.5±1.7 days) was significantly longer than with E2 (7.8±1.9 days). Stimulation and embryological characteristics were similar. Ongoing pregnancy rates (46.0% vs. 44.0%; risk difference, -2.0% [95% CI -21.2% to 17.3%]), as well as implantation (43.5% vs. 47.4%), clinical pregnancy (50.0% vs. 48.0%), clinical miscarriage (7.1% vs. 7.7%), and live birth (42.0% vs. 40.0%) rates were comparable between groups.This is the first study to directly compare these two methods of cycle scheduling in GnRH antagonist cycles. Our results fail to show statistically significant differences in ongoing pregnancy rates between pretreatment with OCP and E2 for IVF with the GnRH antagonist protocol. Although the study is limited by its sample size, our results may contribute to a future meta-analysis. An interesting future direction would be to extend our study to women with decreased ovarian reserve, as these are the patients in whom an increase in oocyte yield-due to the hypothetical beneficial effect of steroid pretreatment on follicular synchronization-could more easily be demonstrated.ClinicalTrials.gov http://NCT01501448.

SUBMITTER: Hauzman EE

PROVIDER: S-EPMC3849807 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial.

Hauzman Erik E EE Zapata Azucena A Bermejo Alfonso A Iglesias Carlos C Pellicer Antonio A Garcia-Velasco Juan A JA

Reproductive biology and endocrinology : RB&E 20130928

<h4>Background</h4>Both oral contraceptive pills (OCPs) and estradiol (E2) valerate have been used to schedule gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles and, consequently, laboratory activities. However, there are no studies comparing treatment outcomes directly between these two pretreatment methods. This randomized controlled trial was aimed at finding differences in ongoing pregnancy rates between GnRH antagonist IVF cycles scheduled with OCPs or E2 ...[more]

PMID: 24074027

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Project description:ImportanceAs prescription drug costs rise, it is important to understand attitudes among primary care physicians and nurse practitioners (NPs) towards generic drugs.ObjectiveWe aimed to examine the generic skepticism index (GSI) among primary care clinicians, and their willingness to discuss and prescribe generic antidepressants (ADs) and generic oral contraceptives (OCPs).DesignWe used a factorial vignette design survey to test 4 factors: message source, message, brand preference, and drug class. Participants were randomized to different combinations of factors.SettingThis was a cross-sectional study.ParticipantsPhysicians registered with the American College of Physicians (ACP) and NPs registered with the American Association of Nurse Practitioners (AANP) participated in the study.Main measuresThe primary outcomes were generic skepticism as measured using the generic skepticism index (GSI), and clinician willingness to discuss and prescribe generics.ResultsSurveys were completed by 56% of physicians (n = 369/661) and 60% of NPs (n = 493/819). Compared with physicians, NPs were younger (p < 0.001), predominantly female (p < 0.001), and differed in the race (p < 0.001). According to the GSI, 16% (n = 138/862) were identified as generic skeptics (18.5% of NPs and 12.7% of physicians, p = 0.023). Generic skeptics had lower odds of willingness to discuss switching (OR 0.22, 95% CI (0.14-0.35), p < 0.001) or prescribe (OR 0.18, 95% CI (0.11-0.28), p < 0.001) generic OCPs. Participants had lower odds of willingness to prescribe generic drugs to patients with brand preference compared with brand-neutral patients (OR 0.64, 95% CI 0.50-0.82, p < 0.001).Conclusions and relevanceGeneric skepticism was associated with lower willingness to discuss or prescribe generic drugs. Clinicians reported lower willingness to discuss switching or prescribe generics for OCPs than for ADs. Patient brand preference hindered generic prescribing. Message source and message type were not significantly associated with outcomes.

Project description:Importance:The Veterans Affairs (VA) health care system is the largest integrated health care system in the United States. Like most US health plans, the VA currently stipulates a 3-month maximum dispensing limit for all medications, including oral contraceptive pills (OCPs). However, 12-month OCP dispensing has been shown to improve continuation of use, decrease coverage gaps, and reduce unintended pregnancy in other practice settings. Objective:To estimate the financial and reproductive health implications for the VA of implementing a 12-month OCP dispensing option, with the goal of informing policy change. Design, Setting, and Participants:A decision model from the VA payer perspective was developed to estimate incremental costs to the health care system of allowing the option to receive a 12-month supply of OCPs up front, compared with the standard 3-month maximum, during a 1-year time horizon. A model cohort of 24?309 reproductive-aged, heterosexually active, female VA enrollees who wish to avoid pregnancy for at least 1 year was assumed. Probabilities of continuation of OCP use, coverage gaps, pregnancy, and pregnancy outcomes were drawn from published data. Costs of OCP provision and pregnancy-related care and the number of women using OCPs were drawn from VA administrative data. One-way and probabilistic sensitivity analyses were performed to assess model robustness. Main Outcomes and Measures:Incremental per-woman and total costs to the VA of allowing for 12-month dispensing of OCPs compared with standard 3-month dispensing. Results:The 12-month OCP dispensing option, modeled from the VA health system perspective using a cohort of 240 309 women, resulted in anticipated VA annual cost savings of $87.12 per woman compared with the cost of 3-month dispensing, or an estimated total savings of $2?117?800 annually. Cost savings resulted from an absolute reduction of 24 unintended pregnancies per 1000 women per year with 12-month dispensing, or 583 unintended pregnancies averted annually. Expected cost savings with 12-month dispensing were sensitive to changes in the probability of OCP coverage gaps with 3-month dispensing, the probability of pregnancy during coverage gaps, and the proportion of pregnancies paid for by the VA. When simultaneously varying all variables across plausible ranges, the 12-month strategy was cost saving in 95.4% of model iterations. Conclusions and Relevance:Adoption of a 12-month OCP dispensing option is expected to produce substantial cost savings for the VA while better supporting reproductive autonomy and reducing unintended pregnancy among women veterans.

Project description:To determine the relative bioavailability of ethinyl estradiol (EE) and gestodene (GSD) after application of a novel transdermal contraceptive patch vs. a standard combined oral contraceptive (COC) pill (study 1), and to evaluate the pharmacokinetics (PK) of EE after application of the EE/GSD patch compared with an EE/norelgestromin (NGMN) patch (study 2).Participants were healthy, nonobese women aged 18 - 45 years (study 1) or 18 - 35 years (study 2). Compositions of study treatments were as follows: 0.55 mg EE/2.1 mg GSD (EE/GSD patch); 0.02 mg EE/0.075 mg GSD (standard COC); 0.6 mg EE/6 mg NGMN (EE/NGMN patch).In study 1, which consisted of 3 treatment periods (each followed by 7 patch- or pill-free days), treatments were administered in one of two randomized orders: either P-M-E (EE/GSD patch (P) every 7 days for 28 days ? COC (M) once-daily for 21 days ? two 7-day patch-wearing periods followed by one 10-day patch-wearing phase (E)), or the same treatments administered in sequence M-P-E. For study 2, participants received either the EE/GSD patch or EE/NGMN patch for seven treatment cycles (one patch per week for 3 weeks followed by a 7-day patch-free interval).In study 1, average daily exposure to EE was similar for treatments P and M; the mean daily area under the concentration-time curve (AUC) ratio of treatment P vs. treatment M for EE was 1.06 (90% confidence interval (CI): 0.964 - 1.16), indicating average daily delivery similar to oral administration of 0.019 - 0.023 mg EE. For unbound GSD, average daily exposure was lower for treatment P vs. treatment M. The mean AUC ratio of treatment P vs. treatment M for unbound GSD was 0.820 (90% CI: 0.760 - 0.885), indicating average daily delivery from the patch of 0.057 - 0.066 mg GSD. Prolonged patch wearing did not result in a distinct decline in GSD and EE serum concentrations. In study 2, AUC at steady state (AUC0-168,ss), average steady-state serum concentration, and maximum steady-state serum concentration for EE was 2.0 - 2.7-fold higher for the EE/NGMN patch vs. the EE/GSD patch. The EE/GSD patch was well tolerated in both studies.Based on the 90% CI of the AUC ratio of oral treatment vs. patch application for unbound GSD and EE, the daily doses of GSD and EE released from the EE/GSD patch over the 7-day application period provided the same systemic exposure as those recorded after daily oral administration of a COC containing 0.02 mg EE and 0.06 mg GSD. The EE/GSD patch showed reduced EE exposure compared with the EE/NGMN patch. Together with its good tolerability, these properties support the EE/GSD patch as an effective and well-tolerated alternative to available transdermal and oral contraceptives.

Dataset Information

Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial.

Publications

Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial.

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